Medtronic Sprint Fidelis® Defibrillator Leads Recalled Because of Possible Malfunction
On October 15, 2007, Medtronic announced that it was suspending all sales of Sprint Fidelis® lead models 6930, 6931, 6948 and 6949, because of the potential for defibrillator lead fractures, which may have contributed to at least 5 deaths and numerous reports of unnecessary shocks in patients with the recalled Medtronic leads.
Medtronic Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.
It is believed that the recalled Medtronic leads have been implanted in over 250,000 patients since 2004. They are connected to defibrillators made by Medtronic or by another defibrillator manufacturer such as Guidant or St. Jude, for which Medtronic supplied the lead. According to Medtronic, 4,000 to 5,000 people with a Sprint Fidelis® leads will experience a fracture within 30 months of having a Medtronic defibrillator implanted. Those patients whose Medtronic Sprint Fidelis® lead fractures may require a risky surgical procedure to have the wire replaced.
If you or a loved one has an implanted defibrillator that uses a recalled Medtronic Sprint Fidelis® lead, please contact our office for a free evaluation.
ADDITIONAL INFORMATION CONCERNING MEDTRONIC SPRINT FIDELIS® DEFIBRILLATOR LEADS and RECALL:
Medtronic Sprint Fidelis® Defibrillator Leads Recall Notice
Medtronic Sprint Fidelis® Defibrillator Leads FDA Statement
Medtronic Sprint Fidelis® Defibrillator Leads Consumer Q & A
